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New Safety Information Identified by the Adverse Event Reporting System (AERS)

Potential Signals of Serious Risks
What is FDA posting?
The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that [...]

FDA Unveils List of 20 Drugs In Side-Effect Probes

Goal Is to Provide Signs of Possibility Of Adverse Effects
By JARED A. FAVOLE
WSJ.com, September 5, 2008 8:07 p.m.
WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early [...]